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​Global Auditing & Remediation Services

FDA, EMA, ISO Mock & PAI Audits
Vendors & Supplier Audits

  • ​​GMP/GLP/GCP GXP Audits - Excipients / APIs
  • Medical Device - QMS/QSR Audits - ISO 13485:2016
  • Vendor - Supplier Audits, CMOs, CDMOs
  • Laboratory Audits - GLP/GCLP - Part 58/OECD GLP
  • 21 CFR Part 11 Systems & Software Compliance
  • Validation Audits / Writing - Process & Equipment
  • Dietary Supplements & Cosmetics Manufacturing
  • Company Acquisitions & Compliance Audits
  • Mock FDA, EU, NMPA & WHO Audits
  • Remediation, Validation & Gap Analysis Reports
  • Clinical Audits, CROs, GCLP, Investigator Sites
GxP Audits



All Subject Matter Experts (SMEs) have the Experience, Training, Education and Background to support your compliance audit and remediation requirements backed by TAG, ASQ and Global Accepted Certifications!

  • GMP Audits - API/Excipients

  • GLP Audits - QC, Testing and LIMs, 

  • Mock FDA/EMA, PAI, Pre-ISO

  • Vendors, Suppliers and Contractors

  • Pharmaceuticals / Supplements

  • Medical Devices / IVDs

  • Cosmetics

  • Biologics, Blood, Cell, Tissue

  • Validation Audits

  • Engineering Audits

  • Document Audits

  • Clinical Audits

  • Investigator Sites

  • Clinical Data Management

  • Clinical Electronic Systems



The Auditing Group SMEs have the Experience to assist with your remediation efforts, whether satisfying a 'For-Cause' US FDA 483, Agency Warning Letter, or audit observations, we have the resources and tools to assist with your successful compliance endeavors.

  • Project Management

  • CAPA Management

  • Procedure Development

  • Protocol Development

  • Design / Build Engineering Analysis

  • As-Built Qualifications

  • Commissioning and Qualifications

  • Validation Services

Turn-key or Hourly SME Quotes!

Gantt Driven Project Management




                            The Auditing Group has                                    teamed up with GMP Boot                                Camps to provide on-site or                              Virtual training for your                                      Employees to satisfy your                                GxP requirements.

  • Basic 1, 2, or 3-day GMP / QMS for Drug, Medical Device, Cosmetics or Dietary Supplements Training

  • Focused Training Programs - Taylored to your Company's Products, Services or Capabilities - Includes an on-site pre-training Audit of your GXP Compliance for training applicability.

Mock FDA - PAI - Supplier Audits

Providing FDA Compliance Consulting, Design/Build, Engineering, Construction, Commissioning and Validation/Qualifications for the FDA / EMA Regulated Industry.

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